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All Studies   Meta Analysis    Recent:   

Another step toward final call on Remdesivir efficacy as a treatment for hospitalized COVID-19 patients: a multicenter open-label trial

Hosseini et al., medRxiv, doi:10.1101/2021.08.13.21261992
Aug 2021  
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Single arm remdesivir trial with 145 hospitalized patients showing no statistically significant difference between "early" and "late" administration, however the treatment delays may be better described as late and very late. The text of the paper defines early and late as less than or more than 7 days from symptom onset, however the CONSORT diagram says during or after 7 days post admission.
Gérard, Zhou, Wu, Kamo, Choi show significantly increased risk of acute kidney injury with remdesivir.
Hosseini et al., 13 Aug 2021, preprint, 15 authors.
This PaperRemdesivirAll
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21261992; this version posted August 13, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license . Title: Another step toward final call on Remdesivir efficacy as a treatment for hospitalized COVID-19 patients: a multicenter open-label trial Running title: Remdesivir efficacy in COVID-19 treatment Authors: Hamed Hosseini1, Anahita Sadeghi2, Payam Tabarsi3, Azin Etemadimanesh4, Ilad Alavi Darazam3, Nasser Aghdami4, Saeed Kalantari5, Mehrdad Hasibi4, Azar Hadadi4, Farhang Babamahmoodi6, Mansooreh Momen-Heravi7, Ahmad Hormati8,9, Yunes Panahi10, Rozita Khodashahi11, Mohammadreza Salehi4* 1. Center for Research and Training in Skin Disease and Leprosy, Tehran University of Medical Sciences. 2. Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran. 3. Department of Infectious Disease, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 4. Department of Infectious Disease, Tehran University of Medical Science, Tehran, Iran. 5. Antimicrobial Resistance Research Center, Iran University of Medical Sciences, Tehran, Iran 6. Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran 7. Department of infectious diseases, faculty of medicine, Kashan university of medical sciences, Kashan, Iran. 8. Gastroenterology and Hepatology Disease Research Center, Oom university of medical sciences, Iran. NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21261992; this version posted August 13, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license . 9. Gastrointestinal and Liver Diseases Research Center, Iran university of medical sciences, Tehran, Iran. 10. Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran 11. Department of Infectious disease and tropical medicine, Faculty of Medicine, Mashhad university of medical sciences, Mashhad, Iran. Corresponding author: Mohammadreza Salehi M.D., Department of Infectious Disease, Tehran University of Medical Sciences. Imam Khomeini hospital complex, Gharib St., Tehran, Iran. Email: salehi.mohamad3@gmail.com , ORCID: 0000-0002-1987-5929, Cellphone: +989123159842 Declaration of interests: Hereby, all authors of this study declare no conflict of interests before, during, and after the study was done. Acknowledgments: Our sincere thanks to Professor Reza Malekzadeh who coordinated and supervised the project. We express our gratitude to the Digestive Diseases Research Institute (DDRI), Tehran University of Medical Sciences. Conducting the study would not have been possible without the efforts of the DDRI team. The authors also would like to express their gratitude for all care workers and patients in study hospitals. This study has been funded and supported by Tehran University of Medical Sciences (TUMS); Grant no. 99-1-97-47143. medRxiv preprint doi:..
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In this study, we aimed to ' 'evaluate the effect of Remdesivir on hospitalized COVID-19 patients’ ' 'outcomes.</jats:p></jats:sec><jats:sec><jats:title>Material and ' 'methods</jats:title><jats:p>This study was an open-label, single-armed, clinical trial on ' 'hospitalized patients diagnosed with COVID-19 who had progressive respiratory symptoms ' 'despite receiving standard care. All patients received Remdesivir and their characteristics, ' 'outcomes, time of treatment initiation, and respiratory support stages during hospitalization ' 'were registered and followed up for 14 ' 'days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>145 patients with ' 'the mean age of 52.89 ± 1.12 years enrolled in this study, 38 (26.2%) died at the end of 14 ' 'days period. The mean time interval from the onset of the symptoms to antiviral treatment was ' '10.63±0.56 days. Thirty deceased patients (78.9%) were men, showing 2.8 times higher ' 'mortality chance compared to women (OR<jats:sub>adj</jats:sub>=2.77; 95%CI=1.08-7.09). The ' 'type of respiratory support on the first day of treatment initiation showed a significantly ' 'lower mortality chance in patients receiving O<jats:sub>2</jats:sub>only than those who ' 'needed non-invasive and/or mechanical ventilation (OR<jats:sub>adj</jats:sub>=3.91; ' '95%CI=1.64-9.32). The start time (early vs late administration) and duration (less or more ' 'than 7 days) of antiviral treatment had no statistically significant association with ' 'mortality or ventilation escalation among the patients (p-value &gt; ' '0.05).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>In this study, ' 'we showed that Remdesivir probably is not effective on the outcome of hospitalized COVID-19 ' 'patients.</jats:p></jats:sec>', 'DOI': '10.1101/2021.08.13.21261992', 'type': 'posted-content', 'created': {'date-parts': [[2021, 8, 13]], 'date-time': '2021-08-13T20:15:19Z', 'timestamp': 1628885719000}, 'source': 'Crossref', 'is-referenced-by-count': 3, 'title': 'Another step toward final call on Remdesivir efficacy as a treatment for hospitalized COVID-19 ' 'patients: a multicenter open-label trial', 'prefix': '10.1101', 'author': [ { 'ORCID': 'http://orcid.org/0000-0003-2368-6749', 'authenticated-orcid': False, 'given': 'Hamed', 'family': 'Hosseini', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-9564-4631', 'authenticated-orcid': False, 'given': 'Anahita', 'family': 'Sadeghi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-8932-5420', 'authenticated-orcid': False, 'given': 'Payam', 'family': 'Tabarsi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-6923-0133', 'authenticated-orcid': False, 'given': 'Azin', 'family': 'Etemadimanesh', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4440-335X', 'authenticated-orcid': False, 'given': 'Ilad Alavi', 'family': 'Darazam', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5390-7878', 'authenticated-orcid': False, 'given': 'Nasser', 'family': 'Aghdami', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-9896-4139', 'authenticated-orcid': False, 'given': 'Saeed', 'family': 'Kalantari', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-8120-6400', 'authenticated-orcid': False, 'given': 'Mehrdad', 'family': 'Hasibi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5080-6887', 'authenticated-orcid': False, 'given': 'Azar', 'family': 'Hadadi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-4239-9569', 'authenticated-orcid': False, 'given': 'Farhang', 'family': 'Babamahmoodi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-8528-8271', 'authenticated-orcid': False, 'given': 'Mansooreh', 'family': 'Momen-Heravi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-1322-1318', 'authenticated-orcid': False, 'given': 'Ahmad', 'family': 'Hormati', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-2504-8356', 'authenticated-orcid': False, 'given': 'Yunes', 'family': 'Panahi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-6514-7308', 'authenticated-orcid': False, 'given': 'Rozita', 'family': 'Khodashahi', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-1987-5929', 'authenticated-orcid': False, 'given': 'Mohammadreza', 'family': 'Salehi', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'issue': '1', 'key': '2021081607550690000_2021.08.13.21261992v1.1', 'first-page': '157', 'article-title': 'WHO declares COVID-19 a pandemic', 'volume': '91', 'year': '2020', 'journal-title': 'Acta bio-medica: Atenei Parmensis'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.2', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S1473-3099(20)30120-1'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.3', 'doi-asserted-by': 'crossref', 'unstructured': 'Jalili, M. , et al., Characteristics and mortality of hospitalized ' 'patients with COVID-19 in Iran: a National Retrospective Cohort Study. ' 'Annals of internal medicine, 2020.', 'DOI': '10.7326/M20-2911'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.4', 'unstructured': 'Cascella, M. , et al., Features, evaluation and treatment coronavirus ' '(COVID-19), in Statpearls [internet]. 2020, StatPearls Publishing.'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.5', 'unstructured': 'Organization, W.H. , Solidarity” clinical trial for COVID-19 treatments. ' 'World Health Organization (WHO). Situation reports. Geneva: WHO. ' '[Accessed: 5 Apr 2020]. Available from: ' 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments, ' '2020.'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.6', 'unstructured': 'Saint-Raymond, A. , et al., Remdesivir emergency approvals: a comparison ' 'of the US, Japanese, and EU systems. Expert Review of Clinical ' 'Pharmacology, 2020: p. 1–7.'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.7', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NE-JMoa2007016'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.8', 'doi-asserted-by': 'crossref', 'unstructured': 'Frediansyah, A. , et al., Remdesivir and its antiviral activity against ' 'COVID-19: A systematic review. Clinical epidemiology and global health, ' '2020.', 'DOI': '10.1016/j.cegh.2020.07.011'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.9', 'unstructured': 'Wang, Y. , et al., Remdesivir in adults with severe COVID-19: a ' 'randomised, double-blind, placebocontrolled, multicentre trial. The ' 'Lancet, 2020.'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.10', 'unstructured': 'Pan, H. , et al., Repurposed antiviral drugs for COVID-19; interim WHO ' 'SOLIDARITY trial results. 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' 'e2187.', 'DOI': '10.1002/rmv.2187'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.14', 'unstructured': 'Madsen, L.W. , Remdesivir for the Treatment of Covid-19-Final Report. ' 'The New England Journal of Medicine, 2020.'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.15', 'doi-asserted-by': 'publisher', 'DOI': '10.1371/journal.ppat.1008570'}, { 'key': '2021081607550690000_2021.08.13.21261992v1.16', 'doi-asserted-by': 'crossref', 'unstructured': 'Liu, Y. , et al., Clinical features and progression of acute respiratory ' 'distress syndrome in coronavirus disease 2019. 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Late treatment
is less effective
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